CDISC Biomedical Concepts in the CDISC Library (https://www.cdisc.org/cdisc-library). The CDISC Biomedical Concepts (BCs) include a two-are available for RECIST 1.1 following the two-layered approach:
- Conceptual/abstract layer that provides standards-agnostic, unambiguous semantic definition largely based on NCIt concepts.
- Implementation layer based on valid CDISC dataset specializations that provide value level metadata definitions that facilitate metadata-driven automation.
SDTM dataset specializations have been defined for TU, TR, and RS datasets. The They are retrievable via the CDISC Library API as JSON output. See the CDISC Biomedical Concepts page for more information https://www.cdisc.org/cdisc-biomedical-concepts.
3.1 Assumptions for the Oncology Disease Response and Supporting Domains Model